The Role of CYP2C19 on the Eradication of H. Pylori Infection:Implication of PK/PD Relationships

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00162877
First received: September 12, 2005
Last updated: November 22, 2005
Last verified: January 2004
  Purpose

The objective of this trial is to find the rationale and the optimal dose and duration of regimen for the eradication of H. pylori infection using different proton pump inhibitors.


Condition Intervention
Peptic Ulcer With H. Pylori Infection
Gastritis With H. Pylori Infection
Drug: Rabeprazole vs. Esomeprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of CYP2C19 Poor Metabolizers and Extensive Metabolizers of PPI in Short-Term Triple Therapy on the Eradication of H. Pylori Infection: Implication of PK/PD Relationships

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the role of CYP2C19 on the eradication of H. pylori infection

Secondary Outcome Measures:
  • implication of PK/PD relationships

Estimated Enrollment: 80
Study Start Date: June 2004
Estimated Study Completion Date: April 2005
Detailed Description:

Helicobacter pylori in known to be closely associated with the pathogenesis of gastroduodenal disorders such as peptide ulcer. Eradication of this bacterium is important in the treatment of these diseases as well as in the reduction of the recurrence. The one-week triple therapy with proton pump inhibitors (PPIs) is now considered to be the standard therapies in the treatment of Helicobacter pylori infection, providing more than 80% eradication rates with few adverse effects. PPIs are mainly metabolized by CYP2C19, which is known to exhibit polymorphisms in both its genotype and phenotype. Based on the PK/PD results of our study on PPI, recently, we have proposed that CYP2C19 poor metabolizers might be subject to advantageous conditions, especially after day-4, for the treatment of H. pylori infection when 20 mg rabeprazole was given twice daily. Our results also suggest a possibility to start the triple therapy on day-4 of rabeprazole treatment to ensure the optimal acid suppression effect for antibiotics to exert the bacteriocidal effect. To find the rationale and the optimal dosing regimen for the eradication of H. pylori infection using different proton pump inhibitors, volunteers of four groups would be included in this study. PPI (rabeprazole or esomeprazole) is given for 7 days. Antibiotics are given starting from day-1 or day-4 of PPI dosing. The eradication rate of H. pylori infection and the PK/PD of PPIs are also evaluated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female dyspeptic patients with H. pylori-positive peptic ulcer or gastritis will be recruited at the university hospital in this study.

Exclusion Criteria:

  • 1)Pregnant or lactating female;*2)Patients have endoscopy-based evidence of gastric malignancy, pyloric obstruction, and esophageal stricture requiring dilation, fresh clot, active bleeding, or perforated ulcers;3)Patients requiring anticoagulants or corticosteroid therapy (at dosages greater than the equivalent of prednisone, 10 mg/day);4)Patients with significant impairment of renal function (creatinine>2mg/dl); liver function impairment (AST and ALT 2x upper limit of normal); severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or acute respiratory disease;5)Patients with a history of esophageal and/or gastric varices;6)Use of other investigational drugs within 30 days prior to the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00162877

Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Chin Yang, M.D. Department of Internal Medicine, National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162877     History of Changes
Other Study ID Numbers: 920505, NTUH93S060
Study First Received: September 12, 2005
Last Updated: November 22, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
rabeprazole, omeprazole, CYP2C19, H. pylori, PK/PD

Additional relevant MeSH terms:
Gastritis
Peptic Ulcer
Helicobacter Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014